Therapeutic composition including carbonated solution

ABSTRACT

The present invention is directed to a therapeutic composition including an active therapeutic ingredient combined with a liquid or solution based carbonated beverage. The invention as described details the use or administration of the therapeutic composition so as to treat a variety of ailments. The present invention is also directed to a method of administering the therapeutic composition to an individual for the purposes of alleviating an ailment. In a further arrangement, the therapeutic composition is provided to a user as a pre-packaged volume containing a single effective dose of the therapeutic agent.

The present invention describes a therapeutic composition that includesa therapeutically active ingredient combined with a carbonated solutionor beverage. The invention also includes a method of administeringand/or formulating a therapeutic composition that includes atherapeutically active ingredient combined with carbonated solution orbeverage.

BACKGROUND OF THE INVENTION

It is known in the art to treat various conditions and illnesses usingoral medications such as expectorants, non-steroid anti-inflammatory(NSAIDs), antihistamines, cough suppressants, mucolytic agents,curatives, neutraceuticais, and antidotes. These oral therapeuticcompositions are supplied to patients in a variety for forms. Forexample, various medications can be supplied in syrups, liquids,powders, tablets, gels, and other ingestible formats.

However, some medications can have an astringent or bitter taste whichdiscourages patients from taking a full dose. However, the format of themedication (liquid, solid, gel etc.) can be used to make a unpleasanttaste

One way to increase active ingredient uptake is through the use ofcarbonation. A carbonated drink is a beverage that ha had cirirbondioxide introduced for some reason.

The process of carbonating a liquid usually involves the introduction ofcarbon dioxide under high pressure. When the pressure is reduced, thecarbon dioxide is released from the solution as small bubbles, whichcauses the solution to become effervescent, or “fizz”. An example ofcarbonation is introducing of carbon dioxide in water, resulting incarbonated water.

Currently, carbonation and carbonated beverages are useful in increasingthe uptake of certain ingredients in the human body. For example,Schroder et al., Absorption of calcium from the carbonated dairy softdrink is greater than that from fat-free milk and calcium-fortifiedorange juice in women, 25 Nutrition Research 737-742 (2005) herebyincorporated by reference in its entirety, describes the use carbonatedbeverages to the absorption of calcium.

Carbonated beverages also can be used to increase the uptake of alcohol,For example, Roberts C. Robinson, Alcohol concentration and carbonationof drinks: the effect on blood alcohol levels, 14(7) Journal of Forensicand Legal Medicine 398-405 (2007), hereby incorporated by reference inits entirety, describes increased uptake of alcohol when mixed withcarbonated beverages.

The prior art attempts to provide carbonationthrough he use ofeffervescentformulations that produce carbonation-like results uponcontact with water. However, there are numerous problems associated witheffervescent formulations.

For example GB2192790, herein incorporated by reference, describeseffervescent mutations comprising from 6 to 32% by weight ofacetylcysteine (NAC), from 35 to 50% by weight of citric acid, from 26to 37% by weight of sodium bicarbonate, from 1 to 1.5% by weight ofaspartame and front 5 to 7% by weight of a flavoring agent in which theweight ratio between citric acid and sodium bicarbonate is from 1.2:1 to1.4:1. The effervescent tablet containing 600 mg of NAC has a totalweight of 1900 mg. Similar effervescent tablets are marketed asFluimucil® 600 and have a total weight of 1.8 g.

EP 0 339 508, herein incorporated by reference, describes mouth-solubleformulations containing NAC, alkaline bicarbonates, carbohydrates andfruit flavorings. The amount of carbohydrates is from 20:1 to 50:1 byweight compared with NAC.

Likewise, EP 0 839 528, herein incorporated by reference, describesmouth-soluble compositions of NAC in which the taste masking is obtainedusing cyelodextrins. The composition described also contains an amountfrom 2 to 15 parts of carbohydrates, preferably from 5 to 10 parts byweight compared with NAC. Even low dosage formulations (100-200 g ofNAC) have a total weight of at least 2 g.

However, eaach of these references describes the use of solid fbrmtablets, in each of the cited references, the liquid and solidcomponents are provided for separately, not as a single carbonatedbeverage.

Therefore, what is needed is a therapeutic composition that includes acarbonated beverage and a therapeutically active ingredient that isincrease uptake of active ingredients, superior product stability, andimprove patient compliance, thereby providing a more effective dose andimproving compliance with a prescribed dosing regimen. What is furtherneeded is a therapeutic composition that has improved taste presentationover existing therapeutically active compositions.

SUMMARY OF THE INVENTION

The present invention is directed to a therapeutic composition includingan active therapeutic ingredient combined with a liquid or solutionbased carbonated beverage. The invention as described details the use oradministration of the therapeutic composition so as to treat a varietyof ailments. In one arrangement, the composition described includes anon-steroidal anti-inflammatory drug, such as naproxen combined with acarbonated beverage. The present invention is also directed to a methodof administering the therapeutic composition to an individual for thepurposes of alleviating an ailment, in a further arrangement, thetherapeutic composition is provided to a user as a pre-packaged volumecontaining a single effective dose of the therapeutic agent.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

By way of overview and introduction, the present invention concerns atherapeutic composition and method for treating various conditions andillnesses using expectorants, anti-inflammatory compounds,antihistamines, herbal supplements, neutraceutical, cough suppressants,mucolytic agents, curatives, and/or antidotes in a composition with acarbonated beverage. More specifically, the present invention isdirected to a composition including a therapeutically active ingredientcombined with a liquid or solution based carbonated beverage. Theinvention as described is directed to the use or administration of thedescribed therapeutic composition in order to treat a plurality ofailments through the use of therapeutically active ingredients incombination with a carbonated solution or beverage.

The present invention is also directed to an orally administeredtherapeutic beverage having excellent physical stability whilecontaining concentrated levels of therapeutically active ingredients. Inone arrangement, carbonated beverage operates as a vehicle forsolubilizing the therapeutic (for example a pharmaceutically active)ingredient along with a hydrophilic solvent, polyoxyalkylene blockcopolymers and/or water. These ingredients are, in one arrangement,provided in specific quantities and ratios relative to one another andthe therapeutic ingredient such that the therapeutic ingredient is alsosolubilized and remains so over extended periods of time. Liquidformulations for oral delivery of therapeutic agents are desirablebecause certain patients, such as children and the elderly, are unableto swallow capsules or tablets.

In a particular formulation, the hydrophilic solvents and water areconfigured in sufficient quantities and ratios so as to facilitate theincorporation of other compounds, such as sweetening agents andlor otherstabilizers, into the composition of the present invention.

The present invention also describes a single use; pre-measured volumeof the carbonated therapeutic composition configured designed to providea full and accurate dose of the active ingredient(s).

It is also known in the art that by introducing carbonation to atherapeutic ingredient in a beverage form, the stability will heincreased which can lead to a better shelf life for patients,pharmacies, hospitals, and other medical organizations. In oneconfiguration, the carbonation of the beverage increases the acidity andlowers the pH of the therapeutic composition promoting a longshelf-life.

Those skilled in the art will appreciate that by introducing carbonationto a therapeutic ingredient in a beverage form, increased absorption andfaster onset of the therapeutic occurs, which provides a significantbenefit any patient.

Furthermore, rapid absorption of the active therapeutic ingredient alsooccurs in the stomach and intestines when combined with a carbonatedformulation. In the present invention this absorption is enhanced by thepresence of dissolved CO₂ in which forms the carbonation component ofthe beverage.

Although carbonation is a naturally occurring phenomenon in somefermented beverages and natural mineral waters, for the purposes of thisinvention, carbonation is the considered the deliberate introduction ofCO₂ as under pressure to the beverage, such as water, with which thebeverage is prepared. The process of infusing gaseous carbon dioxide(CO₂) into liquids to produce a carbonated beverage, i.e. carbonation,is well known in the prior art.

The solubility of CO₂ in water is a function of temperature andpressure. At a standard pressure of 1 atmosphere (Atm.) and atemperature of 15.60 C., water will dissolve a quantity of CO₂ equal toits own volume (i.e. 1.86 g of dissolved CO₂). This serves as the basisto describe levels of carbonation in carbonated beverages, based on gasvolumes.

Typically in carbonated soft drinks, different gas volumes arecharacteristic of different flavors. The more acidic flavors such ascolas, lemonades, tonic and soda waters typically have gas volumesbetween 3.0 and 4.0. The sweeter fruit flavors and those of cream sodashave lower carbonation levels typically in the range of 2.5 to 2.8 gasvolume and sparkling mineral waters often less and 2.0 gas volumes asdescribed in (Shachman, M.) (2005) The Soft Drinks Companion—A TechnicalHandbook for the Beverage Industry, CRC Press, Boca Raton, Fla., U.S.A.;pp. 167-177, herein incorporated by reference in its entirety.

When dissolved in water, CO₂ forms carbonic acid which, although a weakacid, does have a pH lowering effect. There are several advantages ofthe formation of the carbonic acid, it contributes to the characteristicacid note of carbonated beverages, it has as contributory effect introubling the growth of undesirable micro-organisms, and mostimportantly, it releases CO₂ to provide the effervescent effect duringconsumption.

In one potential arrangement, the carbonated beverage of the presentinvention contains additives such as natural flavors, artificial flavorsor sweeteners, stabilizers, or consumable acids. Furthermore, in somearrangements, the carbonated beverage will contain caffeine, Forexample, the caffeine content of the carbonated beverage is about 43/mg.

Those skilled in the art will recognize that a variety of therapeuticingredients are suitable for inclusion into the carbonated therapeuticbeverage described. For instance, it is possible to include effectivesingle dosage, or extra strength dosages of therapeutically activeingredients such as dextromethorphan, pseudoephedrine, acetaminophen,terfenadine, guaifenesin, trimethoprim, prednisolone, ibuprofen,prednisolone sodium phosphate, methacholine, neostigmine, epinephrine,albuterol, pseudoephedrine hydrochloride, diphenhydramine,chlorpheniramine maleate, phenothiazine, chlorpromazine,chlordiazepoxide, amitriptyline, barbiturates, diphenylhydantoin,morphine, demerol, codeine, lomotil, lidocaine, salicylic acid,sulfonamides, prednisolone sodium phosphate, chloroquine, vitaminpreparations, minerals, antibiotics compounds, antiadrenergic compounds,antiserotonergic compounds, anticholinergic compounds, antihistaminergiccompounds, antipsychotic compounds, anti-depressive compounds and herbalsupplements.

Acetykysteine

As an example of the present invention, the carbonated therapeuticcomposition contains acetyleysteine (or N-acetylcysteine). Morespecifically, the therapeutic composition relates to a carbonatedbeverage composition containing acetylcysteine in a single dose. Thoseskilled in the art will appreciate that the quantity of the activetherapeutic ingredient is selected based on different dosage strengthformulations. For example, one dosage formulation has a regular strengthquantity. Alternatively, a different formulation has an extra strengthformulation. For example, in one arrangement, a carbonated therapeuticcomposition is provided wherein the amount of acetylcisteine is at least300 mg.

Furthermore, those skilled in the art are aware that some therapeuticingredients or agents, such as N-acetylcisteine (NAC), have itsunpleasant taste which is difficult to mask. This is especially true inhigh dosage formulations (such as 600 mg formulations ofN-acetylcisteine).

The present invention describes a carbonated beverage having a highdosage (for example, a 600 mg dosage of N-acetylcisteine) of thetherapeutic component. In this high-strength dosage formulation, thecarbonated therapeutic beverage or solution also includes additional orcomplementary compounds to adjust the flavor profile or organolepticproperties of the beverage in order to provide increased compliance withthe dosage regimen.

In a further arrangement, a carbonated therapeutic composition isprepared with a dosage range for a given therapeutic agent (for example,naproxen in the amount of 50-800 mg per day) depending upon thenecessary requirements of the user. in this arrangement, a suitablecombination of elements will be combined so as to provide a palatable ordesired flavor to the composition.

In an alternative arrangement, the carbonated therapeutic compositionincludes the use of sweeteners and/or flavoring profile modificationagents in quantities sufficient to provide a particular flavor or flavorprofile (for example, orange or grape-flavored) designed to enhanceadministration compliance of the therapeutic agent.

The unpleasant tastes of some therapeutic compounds result fromdegradation products (mainly sulphides and disulphides). This unpleasanttaste is more pronounced when the therapeutic form is stored forextended periods at high temperatures. One feature of the presentinvention is to address unpleasant flavor outcomes in therapeuticcompounds (such as N-acetylcisteine) by combining the carbonatedtherapeutic composition with a flavoring and stabilizing agents insufficient ratios and quantities so as to mask the taste of a singledosage volume of the therapeutic compound, but sufficiently stabilizingso as to provide increased shelf-life of the carbonated therapeuticcomposition in variable temperature settings.

Those skilled in the art will appreciate that alternative forms anddosage ranges of the described carbonated therapeutic composition iscontemplated and envisioned. By way on non-limiting example, thefollowing formulations and compounds are exemplary of the presentinvention.

Diphenhydramine

In one arrangement, the carbonated therapeutic composition containsdiphenhydramine. More particularly, the present invention relates to acarbonated therapeutic composition beverage containing diphenhydraminein a single dose regular or extra strength formulation. Diphenhydramineis known chemically as 2-(benzhydroxyl)-N,N-dimethylethylamine. However,those skilled in the art will appreciate that alternative forms andarrangements of the described compound are envisioned and understood. Itis also known in the art to make that the uses of sleep aid, antiemetic,or as an antihistamine

Those skilled in the art will appreciate that alternative forms, dosageranges and compositions necessary to provide an effect amount of thetherapeutic composition in order to achieve these therapeutic results ina variety of different age groups, body types and health states.

Brompheniramine

In a further arrangement, a carbonated beverage formulation including atherapeutic agent is provided wherein the therapeutic agent isbrompheniramine, (and optionally pseudoephedrine and dextromethorphan).In one arrangement the therapeutic agent is provided in a quantitysufficient for a single use, regular strength dose, in a furtherarrangement, the composition described contains at least 10 ml ofbrompheniramine.

Those skilled in the art will appreciate that alternative forms, dosageranges and arrangements of the described carbonated formulationincluding the described therapeutic ingredient are envisioned andunderstood.

Dextromethorphan

In a further arrangement of the invention described, the therapeuticallyactive ingredient of the carbonated therapeutic compound isdextromethorphan. In one envisioned therapeutic beverage formulation,the carbonated beverage contains a range of effective amounts ofdextromethorphan. Those skilled in the art will appreciate that sonicuses of dextromethorphan is used as an antitussive.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Guaifenesin

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes guaifenesin. Those skilled in the art willappreciate that in one arrangement, the active ingredient of a giventherapeutic compound is guaifenesin. In one envisioned therapeuticbeverage formulation, the carbonated beverage contains a range ofeffective amounts of guaifenesin. For example, the active ingredient isincluded in sufficient quantities for a regular, extra-strength, orchild dosages. Those skilled in the art will appreciate that some usesof guaifenesin are as a mucolytic and expectorant.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Ibuprophen

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes ibuprophen. Those skilled in the art willappreciate that in one arrangement, the active ingredient of a giventherapeutic compound is ibuprophen. In one envisioned therapeuticbeverage formulation, the carbonated beverage contains a range ofeffective amounts of ibuprophen. For example, the active ingredient isincluded in sufficient quantities for a regular, extra-strength, orchild dosages. Those skilled in the art will appreciate that some usesof ibuprophen are as an antitussive.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Meclizine

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes meclizine. Those skilled in the art willappreciate that in one arrangement, the active ingredient of a giventherapeutic compound is meclizine. In one envisioned therapeuticbeverage formulation, the carbonated beverage contains a range ofeffective amounts of meclizine. For example, the active ingredient isincluded in sufficient quantities for a regular, extra-strength, orchild dosages. Those skilled in the art will appreciate that some usesof Meclizine are as an antiemetic.

However, those skilled in the art will appreciate that alternativefarms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Caffeine

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes caffeine. Those skilled in the art willappreciate that in one arrangement, the active ingredient of a giventherapeutic compound is caffeine. In one envisioned therapeutic beverageformulation, the carbonated beverage contains a range of effectiveamounts of caffeine. For example, the active ingredient is included insufficient quautities for a regular, extra-strenth, or child dosages.Those skilled in the art will appreciate that some uses of caffeine areas a stimulant.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Acetaminophen

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes acetaminophen. Those skilled in the artwill appreciate that in one arrangement, the active ingredient of agiven therapeutic compound is acetaminophen. In one envisionedtherapeutic beverage formulation, the carbonated beverage contains arange of effective amounts of acetaminophen. For example, the activeingredient is included in sufficient quantities for a regular,extra-strength, or child dosages. Those skilled in the art willappreciate that some uses of acetaminophen are as an analgesic.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Dimenhydrinate

In a further arrangement of the invention described, the carbonatedtherapeutic compound includes dimenhydrinate. Those skilled in the artwill appreciate that in one arrangement, the active ingredient of agiven therapeutic compound is dimenhydrinate. In one envisionedtherapeutic beverage formulation, the carbonated beverage contains arange of effective amounts of dimenhydrinate. For example, the activeingredient is included in sufficient quantities for a regular,extra-strength, or child dosages. Those skilled in the art willappreciate that some uses of dimenhydrinate are as an antihistamine,antiemetic, and sleep aid.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Doxylamine

In an alternative atrangement of the invention described, thetherapeutically active ingredient of the carbonated therapeutic compoundis doxylamine. Those skilled in the art will appreciate that doxylamine,can be described by the chemical name(flS)-A/,A/-dimethyl-2-(1-phenyl-1-(pyridin-2-yl ethoxy) ethanamine. Inone arrangement, the carbonated therapeutic composition containsdoxylamine in sufficient quantities in order to be effective for themanagement of insomnia. Those skilled in the art will appreciate thatdoxylamine is applicable as a sleep aid, antiemetic and/orantihistamine.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Naproxen

In an alternative arrangement of the invention described, thetherapeutically active ingredient of the carbonated therapeutic compoundis naproxen. Those skilled in the art will appreciate that in onecomposition or formulation the described carbonated beverage contains aneffective therapeutic quantity of naproxen. Naproxen is known as aNon-steroidal anti-inflammatory.

However, those skilled in the art will appreciate that alternativefirms, dosages quantities and arrangements of the described compound areenvisioned and understood.

Pseudoephedrine

In an alternative arrangement of the invention described, thetherapeutically active ingredient of the carbonated therapeutic compoundis pseudoephedrine. In a further arrangement the pseudoephedrinecomponent of the therapeutic compound is pseudoephedrine. In oneconfiguration the carbonated beverage therapeutic composition comprisingpseudoephedrine also includes a liquid excipient base. It is well knownin the art that pseudoephedrine is used as a decongestant.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities an arrangements of the described compound areenvisioned and understood.

Yottimbe Bark Extract

A further embodiment of the carbonated therapeutic composition includesYohimbe barkextract. It is also known in the art that Yohimbe barkincreases blood flow.

However, those skilled in the art will appreciate that alternativeforms, dosages quantities and arrangements of the described compound areenvisioned and understood.

In further or alternative arrangements, the compositions so described,also include vitamins. For example, the carbonated composition includesa therapeutically or therapeutically active ingredient in combinationwith a vitamin, such as an A or B-series vitamin B6 (pyridoxine) or B3(Niacin).

In further or alternative arrangements, the compositions so describedalso include elements such as aluminum, calcium as well as antifoamingagents such as simethicone. Those skilled in the art will appreciatethat that consumable quantities of aluminum, has antacid functions.Furthermore, those skilled in the art will appreciate that calcium, inconsumable quantities, has antacid functions. Those skilled in the artwill also appreciate that simethicone and other anti-foaming agents haveanti-flatulent functions.

In one arrangement the carbonated therapeutic composition has at leasttwo active ingredients configured to work in a synergistic manner so asto alleviate multiple symptoms afflicting a user. In a furtherconfiguration, the pH value of the carbonated beverage is below 7. In afurther configuration, the pH value of the carbonated beverage is below4. In as further configuration of the beverages described, the gasvolume is at least 2. In an additional example of the thregoing, the gasvolume is at least 3.

In further or alternative arrangements, the compositions so describedalso include herbal supplements. For example, and in no way limiting,the described compositions, in one particular composition, include oneor more of Aloe Vera, Bilberry, Black Cohosh, Cat's Claw, Chaste berry,Cranberry, Dandelion, Echinacea, Ephedra, Evening Primrose Oil,Feverfew, Flaxseed/Flaxseed, Oil, Garlic, Ginger, Ginkgo, Ginseng Asian,Goldenseal, Green Tea, Hawthorn, Horse Chestnut, Kava, Licorice, RootMilk Thistle, Mistletoe, Red Clover, Saw Palmetto, St. John's. Wortand/or Valerian. These optional ingredients are included in thecomposition in an amount sufficient to perform their intended tunctionwithout compromising the benefits associated with the present invention.

The carbonated therapeutic composition, in one or more arrangements,incudes optional ingredients traditionally included in orallyadministered beverage compositions. These optional ingredients , but arenot limited to, dyes, fragrances, preservatives, antioxidants, aandsimilar types of compounds. Specific optional ingredients include, but,are not restricted to surfactants including tyloxapol, polysorbate 80,lauroglycol 90, polyox 40 stearate, capryol 90, polymers includingpolyvinylpyrmlidone, hydroxypropyl methyl cellulose, beta-cyclodextrins,or solvents, such as propylene carbonate, n-methylpyrrolidone,transcutol, dimethylisosorbide and mixtures thereof. These optionalingredients are included in the composition in an amount sufficient toperform their intended function without compromising the benefitsassociated with the present invention.

While the invention has been pa.rticularly shown and described withreference to a preferred embodiment thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the spirit and scope of theinvention.

What is claimed:
 1. A therapeutic composition niduding at least oneactive therapeutic ingredient combined with a carbonated beverage. 2.The therapeutic composition of claim 1, wherein the at least one activetherapeutic ingredient is selected from a group comprising:expectorants, NSAIDs, antihistamines, sleep aids, antiemetic agents,anti-nausea agents, antitussive agents, mucolytic agents, stimulants,and analgesics.
 3. The therapeutic composition of claim 1, wherein theat least one active therapeutic ingredient is selected from a groupcomprising: acetaminophen, acetylcysteine, dextromethorphan, doxylamine,terfenadine, guaifenesin, ibuproten, neostigmine. epinephrine,.albuterol, pseudoephedrine, diphenhydramine, dimenhydrinate,chlorpheniramine, chlorpromazine, naproxen, phenylephrine, loratadine,ephedrine, brompheniramine, and, Yohimbe Bark Extract.
 4. Thetherapeutic composition of claim 2, wherein the active therapeuticingredient is N-acetylcysteine.
 5. A combined therapeutic compositionhaving at least two therapeutic components and a beverage component,wherein the beverage component has a gas volume value of at least 2.0.6. The therapeutic composition of claim 5, wherein at least onetherapeutic component is a therapeutically effective amount ofdiphenhydramine.
 7. A method of treating one or more symptoms of amedical condition, in which the method comprises: administering atherapeutic composition comprising as therapeutically active ingredientcombined with a carbonated beverage, wherein the gas volume value of thecarbonated beverage is at least 2.0.
 8. The method of claim 7, whereinthe medical condition is selected from cough and the therapeuticallyactive ingredient is dextromethorphan or therapeutically acceptable saltthereof.
 9. The method of claim 7, wherein the therapeutically activeingredient is doxylamine or a therapeutically acceptable salt thereof.10. The therapeutic composition of claim 1, wherein at least one activetherapeutic ingredient is an effective amount of naproxen.
 11. Thetherapeutic composition of claim 2, wherein the therapeutic ingredientalso include a herbal supplement.
 12. The therapeutic composition ofclaim 5, wherein at least one of the therapeutic components includes atleast one of an antiadrenergic compound, antiserotonergic compound,anticholinergic compound, antihistaminergic compound, antipsychoticcompound, or anti-depressive compound,
 13. The therapeutic compositionof claim 1, wherein the composition further includes at least one of, avitamin preparation, bioavallable minerals, bioavailable metals,barbiturates, sulfonamides, prednisolone, or sodium phosphate.
 14. Themethod of claim 7, wherein the medical condition is insomnia
 15. Themethod of claim 7, wherein the medical condition is an allergic responseor reaction.
 16. The method of claim 7, wherein the medical condition isnausea.
 17. The method of claim 16, wherein at least one activetherapeutic ingredient is an effective amount of meclizine.
 18. Thetherapeutic composition of claim 1, wherein at least one activetherapeutic ingredient is an effective amount of acetaminophen.
 19. Thetherapeutic composition of claim 1, wherein at least one activetherapeutic ingredient is an effective amount of caffeine.